S14 Ep2: FDA Approval Insights: Zongertinib in HER2-Mutated NSCLC: With Ticiana Leal, MD, and Misako Nagasaka, MD, PhD

In today’s episode, supported by Nuvation Bio, we spoke with Joel Neal, MD, PhD, and Christian Rolfo, MD, PhD, about the FDA approval of taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic, ROS1-positive non–small cell lung cancer (NSCLC). Dr Neal is a professor of medicine in the Division of Oncology at the Stanford Cancer Institute at Stanford University in Palo Alto, California. Dr Rolfo is the director of the Division of Medical Oncology at The Ohio State University Comprehensive Cancer Center—James and a professor in the College of Medicine at The Ohio State University in Columbus. In our conversation, Drs Neal and Rolfo discussed the significance of this approval, key data from the pivotal phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials, and taletrectinib's current role in the NSCLC treatment paradigm.

In today’s episode, supported by Boehringer Ingelheim, we spoke with Ticiana Leal, MD, and Misako Nagasaka, MD, PhD, about the FDA approval of zongertinib (Hernexeos) for previously treated patients with HER2 TKD–mutant advanced non–small cell lung cancer (NSCLC). Dr Leal is an associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia; as well as medical director of the Clinical Trials Office and leader of the Lung Cancer Disease Team at the Winship Cancer Institute of Emory University. Dr Nagasaka is an associate professor of medicine in the Division of Hematology and Oncology at the University of California, Irvine (UCI) School of Medicine; as well as a medical oncologist at UCI Health. In our conversation, Drs Leal and Nagasaka discussed the significance of this approval, key efficacy and safety findings from the pivotal phase 1 Beamion LUNG-1 trial (NCT04886804), and where zongertinib currently fits into the NSCLC treatment paradigm.

In today’s episode, supported by Autolus, we spoke with Aaron Logan, MD, PhD, and Bijal Shah, MD, MS, about the evolving use of obecabtagene autoleucel (obe-cel; Aucatzyl) in the relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treatment paradigm. Dr Logan is an associate professor of clinical medicine in the Division of Hematology/Oncology at the University of California, San Francisco (UCSF) School of Medicine, as well as a member of the UCSF Helen Diller Family Comprehensive Cancer Center. Dr Shah is an associate member in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida.  In our conversation, Drs Logan and Shah discussed where obe-cel currently fits into the B-ALL treatment paradigm, how the use of this agent might expand going forward, and what the future looks like for the broader CAR T-cell therapy development field in ALL. 

In today’s episode, supported by Immatics, we spoke with Jason Luke, MD, about the development of the PRAME-directed T-cell receptor (TCR) T-cell therapy IMA203 in the ongoing phase 3 SUPRAME trial (NCT06743126) in patients with previously treated, unresectable or metastatic cutaneous melanoma. In our conversation, Dr Luke discussed the rationale for evaluating IMA203 in patients with cutaneous melanoma, the mechanism of action of this novel drug, the design of this study, earlier data that support the continued investigation of this agent in this population, and what these findings may mean for the future of TCR therapy in melanoma.

In this podcast, experts Erminia Massarelli, MD, PhD, MS; Jorge J. Nieva, MD; Sandip Patel, MD; and Ignacio I. Wistuba, MD, discuss new therapies for patients with c-Met–overexpressing non–small cell lung cancer.

In today’s episode, we spoke with Masatoshi Kudo, MD, about the evolving treatment landscape in hepatocellular carcinoma (HCC) and how recent comparative analyses are helping refine the use of first-line immunotherapy-based regimens. Dr Kudo is a professor and chairman in the Department of Gastroenterology and Hepatology at Kindai University Faculty of Medicine in Osaka, Japan.

In today’s episode, supported by Daiichi-Sankyo, we spoke with Ronan J. Kelly, MD, MBA, FASCO; and Michelle Shiller, DO, AP/CP, MGP, about HER2 immunohistochemistry (IHC) testing in non–small cell lung cancer (NSCLC). Kelly is director of the Charles A. Sammons Cancer Center and chief science officer at Baylor University Medical Center in Dallas, Texas; the W.W. Caruth Jr. Endowed Chair of Immunology at Baylor University Medical Center; chief of Oncology at Baylor Scott & White Health System; founder and medical director of the Texas Cancer Interception Institute; a clinical professor at the Texas A&M University College of Medicine; an adjunct associate professor of oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland; and a professor in the Clinical Sciences Division at the Translational Genomics Research Institute in Phoenix, Arizona. Shiller is a molecular genetic pathologist at Baylor University Medical Center.  In our conversation, Drs Kelly and Shiller discussed the importance of performing IHC testing for HER2 in NSCLC, how IHC results may influence treatment decision-making beyond the scope of next-generation sequencing results, and recommendations for more efficient and collaborative IHC testing implementation in clinical practice. 

In today’s episode, we spoke with Nisha Joseph, MD, and Hans Lee, MD, about the FDA's accelerated approval of linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Joseph is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia. Lee is the director of Myeloma Research at the Sarah Cannon Research Institute in Nashville, Tennessee.  In our conversation, Drs Lee and Joseph discussed the significance of this approval, key data from the pivotal phase 1/2 LINKER-MM1 trial (NCT03761108), and where linvoseltamab fits into the relapsed/refractory myeloma treatment paradigm alongside other approved agents. 

In our conversation, Dr Akhave discussed the addition of toripalimab (Loqtorzi), a PD-1 inhibitor, to the NCCN Guidelines following its launch in the United States. Supported by data from the phase 3 JUPITER-02 trial (NCT03581786), toripalimab is now incorporated into frontline therapy for patients with recurrent metastatic or de novo metastatic Epstein–Barr virus (EBV)–positive NPC, in combination with gemcitabine and cisplatin. He explained how this regimen has produced substantial improvements in progression-free survival (PFS), nearly tripling median PFS compared with chemotherapy alone, while maintaining a manageable safety profile.

In this episode, Raval welcomed David A. Frank, MD, PhD, FACP, who is director of the Division of Hematology and a professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine. He also serves as director of the Winship Innovation Initiative and as an advisor to the Morningside Center for Innovative and Affordable Medicine within the Woodruff Health Sciences Center.